To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-09-23, after 2015-07-25 start.
Reason given by the sponsor: “efficacy”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-09-23. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: or equalequal toulngreaterto determine
Phrases that lowered it: participantpharmacokineticssingle dosekgmale -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 11.1% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Sponsor's past trials: 805 (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 59 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Blinding: quadruple (lowers risk) · Design
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Number of arms: 4 (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 4 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.5 (typical: 18)
- Maximum age
- 69 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 805 (typical: 32)
- Sponsor's past termination rate
- 11.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 59 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- ferroquine
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Study to Investigate the Clinical and Parasiticidal Activity and Pharmacokinetics of Different Doses of Artefenomel and Ferroquine in Patients With Uncomplicated Plasmodium Falciparum Malaria NCT03660839 · started 2018 · scored riskier than 18% of active trials completed
- Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria. NCT02083380 · started 2014 · scored riskier than 42% of active trials completed
- Dose Ranging Study of Ferroquine With Artesunate in African Adults and Children With Uncomplicated Plasmodium Falciparum Malaria NCT00988507 · started 2009 · scored riskier than 55% of active trials terminated
- Efficacy and Safety Study of Tafenoquine (TQ) Co-administered With Dihydroartemisinin-piperaquine (DHA-PQP) for the Radical Cure of Plasmodium Vivax (P. Vivax) Malaria NCT02802501 · started 2018 · scored riskier than 39% of active trials completed
- Ph 2B/3 Tafenoquine (TFQ) Study in Prevention of Vivax Relapse NCT01376167 · started 2014 · scored riskier than 13% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.